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临床试验/NCT06850961
NCT06850961招募中不适用

A Digital Health Intervention for Promoting Self-management in Patients with Chronic Obstructive Pulmonary Disease - a Feasibility Study

Western Norway University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Health related outcome

研究概览

简要总结

Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.

详细描述

This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed.

50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited.

A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design.

Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically.

A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of Chronic Obstructive Pulmonary Disease
  • •Mucus-related issues ≥3 times per week
  • •Speak and write Norwegian
  • •Ability to independently operate a smartphone and/or iPad

排除标准

  • •Severe mental illness
  • •Substance abuse that hinder participation in the study

研究组 & 干预措施

Digital health intervention group

Experimental

Patients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion.

干预措施: Digital health intervention by using a mobile application (Device)

Digital health intervention group

Experimental

Patients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion.

干预措施: Feasibilty study and qualitative interview studies (Other)

结局指标

主要结局

Health related outcome

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Generalized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome

Health related outcomes

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

- Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome

Health literacy

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Health Literacy Questionnaire (HLQ) (44 items, 9 domains) - Health literacy was measured using three domains of the HLQ; 3) Actively managing my health, 6) Ability to engage actively with health-care providers and 9) Understand health information well enough to know what to do. Domains 1-5 are scored 1-4, and domains 6-9 are scored 1-5. Lower score indicates lower levels of health literacy.

Satisfaction with treatment

时间窗: End of treatment at 8 weeks and the end of treatment at 6-month follow-up

Patients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome

Recruitment rate

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Recruitment rate (n, %)

Intervention adherence

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Intervention adherence (n, %)

Adverse events

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Adverse events (n, %)

Physical functioning

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome

Exacerbations, hospital admissions and use of healthcare services

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

The number of exacerbations, hospital admissions and use of healthcare services (n)

Health education and self-management

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Health Education Impact Questionnaire (heiQ) (48 items, 8 domains) - is used to measure helath edcuation and self-management. We are using three domains of the heiQ; 2) Health related behaviour, 3) Skill and technique acquisition and 5) Self-monitoring and insight. Scores ranges from 1-4. Lower score indicates lower levels of health education impact and self-management.

Dropout rate

时间窗: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

Dropout (n, %)

次要结局

未报告次要终点

研究者

发起方
Western Norway University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bente Frisk

Professor

Western Norway University of Applied Sciences

研究点 (1)

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